Measuring arterial blood volume changes and heart pumping efficiency
A Pilot Clinical Study to Assess Correlation Between Arterial Blood Volume Status and Cardiac Efficiency, and HemoCept Device Data in Trans-Aortic Valve Replacement (TAVR} Surgery
HemoCept Inc. · NCT07205341
This pilot will test whether the HemoCept device can detect changes in arterial blood volume and heart pumping efficiency in adults with aortic valve stenosis who are being treated at the participating center.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | HemoCept Inc. (industry) |
| Locations | 1 site (Boulder, Colorado) |
| Trial ID | NCT07205341 on ClinicalTrials.gov |
What this trial studies
This observational pilot uses the HemoCept device to measure arterial blood volume and indices of cardiac efficiency in adults with aortic valve stenosis who require trans-aortic valve replacement. Participants will be enrolled at a single participating healthcare facility and monitored according to the study protocol before, during, or after valve replacement as specified by investigators. The study seeks to demonstrate the device's ability to detect physiologically meaningful changes rather than to change clinical care. Common exclusions include pregnancy, breastfeeding, and a personal history of long QT syndrome, cardiac channelopathies, or seizures. Consent and HIPAA authorization are required and participants must be treated by the participating site.
Who should consider this trial
Good fit: Adults aged 18 to 80 with aortic valve stenosis who are receiving care at the participating facility and require trans-aortic valve replacement, who can provide informed consent and meet study requirements, are ideal candidates.
Not a fit: People who are pregnant, breastfeeding, planning pregnancy, or who have a history of long QT syndrome, cardiac channelopathies, or seizures, or who are not undergoing trans-aortic valve replacement at the participating site are unlikely to benefit from this pilot.
Why it matters
Potential benefit: If successful, the HemoCept device could give clinicians a noninvasive way to track arterial blood volume and heart efficiency around valve replacement, potentially improving monitoring and decision-making.
How similar studies have performed: Device-based hemodynamic monitoring approaches have shown promise in research settings, but HemoCept's use for detecting arterial blood volume and cardiac efficiency in this specific patient group is an early, relatively untested pilot.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects or representatives must have voluntarily signed the informed consent form before any study related procedures. * Subjects can be any gender but must be between (and including) the ages of 18 and 80. * Subject ls being treated by the participating healthcare facility . ., Subject requires a trans-aortic valve replacement. * Subject is able and willing to provide informed consent and HIPM authorization. * Subject is able and willing to meet all study requirements. Exclusion Criteria: * Subject is pregnant, breast-feeding, or intends to become pregnant during the course of the study. * Subject has a personal medical history that includes: * Long O-T syndrome * Cardiac channelopathies * Seizures
Where this trial is running
Boulder, Colorado
- Boulder Heart — Boulder, Colorado, United States (RECRUITING)
Study contacts
- Principal investigator: Jamie Doucet, MD — Boulder Heart
- Study coordinator: Katharine Adkins
- Email: kathari.adkins@bch.org
- Phone: 303-442-2395
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Aortic Valve Stenosis